A Phase 3 interventional study of Clopidogrel and Placebo in Kidney Failure and Hemodialysis Fistula Thrombosis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 3, Interventional, and Prevention
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Among 553 studies in Renal Insufficiency with a site in United States — 40 open to participants now, 57 under way, 3 of them phase 3. Renal Insufficiency · United States.
Among the 553 studies in Renal Insufficiency with a site in United States, this one is the 16th largest by enrollment of the 468 interventional ones that give a count, is one of 17 that started in 2003, is one of 45 in phase 3, and was the 360th registered.
1,412 studies on the registry are indexed under Renal Insufficiency; 145 are open to participants now.
Browse Renal Insufficiency studies →40 of the 553 studies in Renal Insufficiency with a site in United States are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States
Ages 18–80 · Healthy volunteers
Sanofi · Sites in United States
Ages 18–75 · Healthy volunteers
Hoffmann-La Roche · Sites in United States
Ages 18–85 · Healthy volunteers
Merck Sharp & Dohme LLC · Sites in United States
Ages 18–80 · Healthy volunteers
Kailera · Sites in United States
Ages 18–85 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 90 Renal Insufficiency studies recruiting now, 47 (52%) set no upper age limit and 18 (20%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
553 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 247 · Phase 2 71 · Phase 3 53 · Phase 4 44
First in 1990; this study’s year is marked. 17 started in 2003.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 877 is above the median of 40 across 1,060 interventional studies indexed under Renal Insufficiency.
Median enrollment 32 across the 468 interventional studies, 182 across the 82 observational. Of the 464 that completed or were terminated, 169 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
334 of 553 have an industry lead sponsor. The 10 most frequent:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has 9 studies filed under Renal Insufficiency — fewer than ten, so there is no comparison to draw.
22 of the studies in Renal Insufficiency with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04020055Phase 3Amicus TherapeuticsA Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease | 2026-12-31 |
| NCT07341516Paris Translational Research Center for Organ TransplantationWorldwide Assessment of Deceased Donor Kidney Utilization | 2026-11 |
| NCT04605679Loma Linda UniversityHepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients | 2026-12 |
| NCT07857837ShionogiStudy of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls | 2026-12-04 |
| NCT03099434Johns Hopkins UniversityExpanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media | 2026-12-07 |
Add all 22 to your calendar (.ics) → With an account.
Among the 553 studies in Renal Insufficiency with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae. This study was originally registered as NCT00067119 which included two protocols, this one and the GRAFT study)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Fistula Study Protocol
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Clopidogrel
Drug: Placebo
Fistula thrombosis (patency failure)
The fistula was classified as patent if a bruit was audible with a stethoscope throughout systole and diastole at least 8 cm proximal to the arteriovenous anastomosis. Fistula patency was assessed by trained study personnel.
Time frame: 6 weeks
Failure to attain suitability for dialysis (ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (>=300 mL/min))
Fistula suitability was defined as the ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (\>=300 mL/min) during 8 of 12 dialysis sessions occurring during a 30-day suitability ascertainment period. For participants receiving maintenance hemodialysis at the time of enrollment and for participants who started maintenance hemodialysis within 120 days after fistula creation, the suitability ascertainment period began between 120 and 150 days after fistula creation surgery.
Time frame: 30 days
Plan to share: Yes — Data are available at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Data sharing details ↗ · repository.niddk.nih.gov
Ran from Jan 2003 to primary completion in Jun 2007, 53 months.
Of 36 phase 3 interventional studies under Renal Insufficiency, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 77. This study's 53 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clopidogrel
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) →